The following data is part of a premarket notification filed by International Medsurg Connection, Inc. with the FDA for Under Buttocks Drape.
Device ID | K042893 |
510k Number | K042893 |
Device Name: | UNDER BUTTOCKS DRAPE |
Classification | Drape, Surgical |
Applicant | INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy, WI 53110 |
Contact | Teodoro Santiago |
Correspondent | Teodoro Santiago INTERNATIONAL MEDSURG CONNECTION, INC. PO BOX 100624 Cudahy, WI 53110 |
Product Code | KKX |
CFR Regulation Number | 878.4370 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2004-10-19 |
Decision Date | 2005-03-11 |
Summary: | summary |